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Trials / Active Not Recruiting

Active Not RecruitingNCT03452878

Evaluation of the Functional Results of Bilateral Amygdalotomy for Refractory Aggressive Patients

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
4 (actual)
Sponsor
Hospital Sirio-Libanes · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Aggressiveness has a high prevalence in the psychiatry population and is of major concern. Though pharmacological treatments are effective for most patients, there is a portion that doesn't respond properly and is considered medically refractory. For them, surgical procedures (i.e. stereotactic lesions) have been performed as an attempt to reintegrate patient into society. The amygdala is a main structure in the control of aggressive behavior and amygdala lesion could improve behavior without neurological or other behavioral impairment. In this study, it will evaluate the functional results of the bilateral amygdala lesion of aggressive refractory patients through neuroimaging, clinical assessment and blood hormonal levels. To better understand the neurobiology of aggression, aggressive patients that are not refractory will also be studied through neuroimaging and hormonal levels.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAggressive behaviorAggressive Behavior Scale, Quality of Life (SF-36) and Agitated Behavior Scale, measurement of thyroid-stimulating hormone (TSH), T4, T3, Cortisol, Luteinizing Hormone (LH), Estradiol, Prolactin, Progesterone, testosterone, and sex hormone-binding globulin (SHBG) and Resonance Magnetic Imaging.

Timeline

Start date
2014-08-06
Primary completion
2018-06-30
Completion
2026-12-31
First posted
2018-03-02
Last updated
2024-10-08

Source: ClinicalTrials.gov record NCT03452878. Inclusion in this directory is not an endorsement.